Issue link: https://www.e-digitaleditions.com/i/733311
USP improves FCC online platform ROCKVILLE, MD—The US Pharmacopeial Convention (USP) improved the online platform for the Food Chemicals Codex (FCC), a col- lection of internationally recognized standards, methods, and information that enables manufacturers and suppli- ers to verify the identity, quality, and purity of food ingredients including probiotics, prebiotics, processing aids, preservatives, and nutrients. FDA issues policy on switching capsule suppliers SILVER SPRINGS, MD— Companies can change suppliers of their hard gelatin capsules without FDA approval when there is no change in capsule composition or appearance, according to "Change in Hard Gelatin Capsule Supplier," which the FDA's Office of Pharmaceutical Quality published August 15. Com- panies now must note the change only in their annual reports. Prior to the new policy, switching capsules was treated as any other change to an approved product and had to be sub- mitted in a prior-approval supplement. Information filed in the annual report must include the contact information of the new capsule shell supplier, USP/NF certification of gelatin from the new capsule supplier, BSE/TSE cer- tification, and the specification for the new supplier's capsules. Health Canada amends OTC drug labeling regulations OTTAWA, ONTARIO—Health Canada released the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products, which calls for using plain language on labels of over-the-counter (OTC) products. The new regulations require compa- nies to include a table in standard for- mat and contact information on the external label and to submit label and package mock-ups for approval. New products must be in compliance by June 13, 2017 and existing products by June 30, 2021. Piramal acquires Ash Stevens MUMBAI, INDIA—Piramal Enter- prises, parent company of Piramal Pharma Solutions, Pithampur, India, acquired Ash Stevens, Riverview, MI, a pharmaceutical CDMO. industry news IPEC China joins ExciPact BRUSSELS, BELGIUM—IPEC Association (China) became the fifth member of ExciPact, an independent, voluntary GMP/GDP certification pro- gram for manufacturers and distributors of pharmaceutical excipients. The group's founding members are IPEC Europe, IPEC-Americas, European Association of Chemicals Distributors, and the Pharmaceutical Quality Group. FDA approves first generic of Tamiflu SILVER SPRINGS, MD—The FDA approved the first generic version of Tamiflu (oseltamivir phosphate), a treatment for influenza A and B for patients 2 weeks of age and older who have had flu symptoms for no more than 48 hours. It also serves as a pre- ventive flu treatment in patients aged 1 year and older. The generic product is made by Natco Pharma and is avail- able in 30-, 45-, and 75-milligram doses. Teva acquires Allergan generic dis- tributor, launches generic Gleevec PETAH TIKVA, ISRAEL—Teva Pharmaceutical acquired Allergan's Anda, a distributor of generic, bran- ded, specialty, and OTC pharmaceuti- cals. It distributes products from more than 300 manufacturers to pharmacies, nursing homes, hospitals, clinics, and physician offices across the USA. In other news, Teva launched a generic version of Gleevec 1 (imatinib mesylate), which was approved by the FDA to treat newly diagnosed adult and pediatric patients with Phila- delphia chromosome positive chronic myeloid leukemia and other indications. Briefly noted… The FDA launched an improved web-based version of the Orange Book, which identifies drug products approved on the basis of safety and efficacy by the Agency. This is the first major revision of the online resource. Pfizer plans to acquire Mediva- tion, a biopharmaceutical company known for developing oncology medications. The acquisition portfo- lio includes Medivation's Xtandi (enzalutamide), an androgen recep- tor inhibitor used to treat advanced metastatic prostate cancer. The FDA approved Pfizer's Troxyca ER (oxycodone hydrochlo- ride and naltrexone hydrochloride) for management of severe pain requiring daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. The extended-release oral capsule is the only oxycodone with oral abuse-deter- rent features described on the label. 8 October 2016 Tablets & Capsules of 6.19 percent. The report cites sev- eral growth factors, including a lenient regulatory framework, increasing healthcare costs, more pharmaceutical retailers, and a shift in distribution channels. The report names Bayer Healthcare, GSK, Johnson & Johnson, Pfizer, and Sanofi as major players that account for 15 percent of total market revenue. Oral OTCs accounted for 60 percent of total market share in 2015. The Americas are forecast to dominate the market during the forecast period. Ingredient Dosing Solutions R&D to Production Engineered Solutions Feed rates start at 1 gram/hour Industries we serve: Pharmaceuticals, Nutraceuticals, BioPharma, Health & Beauty, Packaging Disc Feeder Technology includes: Dosing/Feeding Multi-Component Blending, Volumetric/Gravimetric Controls Batch & Continuous Processes Quick Change Design To learn more p 856.472.0268 email sales@orbetron.com or visit www.orbetron.com